This invention relates to a device for the simultaneous delivery into a live body of multiple medication products, pharmaceuticals, nutritional products and inert materials.
Most medications presently ingested by patients contain significant amount of inert materials or fillers. These inert materials are generally present due to the concentrated nature, and thus small volume, of the actual active ingredient in the medication. If only the active ingredient was presented to a patient, it would be of a size which was too small for the patient to comfortably handle, resulting in either the patient dropping or losing the medication or the patient ingesting an overdose of the medication.
As used herein, the words “pill”, “tablet”, “capsule”, “gel cap” and “soft-gel” are used interchangeably (unless the context at any section hereof otherwise dictate to the contrary, or unless specifically otherwise limited in scope at a particular section hereof), and encompass all other mechanisms and means for delivery of medication products into a live body, including but not necessarily limited to pills, tablets, capsules, gel caps or soft-gels.
As used herein, “Pill” means and includes pills, tablets, capsules, gel caps, soft gels and all other mechanisms and means for delivery of medication products to a live body.
As used herein, the words “medication product” includes and encompasses, but is not limited to, prescription drugs, non-prescription drugs, over-the-counter drugs, nutritional supplements and inert “filler” materials used in conjunction with any of the foregoing.
As used herein, the words “container” and “containment means” includes and encompasses not only the traditional medication capsule, pill, gel cap, soft-gel, suppositories, skin patches and sublingual applications, but also includes and encompasses any and all other medication delivery mechanisms and means.
As used herein, the words “outer contained” means the container or containment means which contains multiple medication products as pills, capsules, gel-caps, soft gels, or liquids, but which itself is not connected with or affixed to another or further container or containment device in chain, train or string fashion, and which is not itself sequentially imbedded within another container, and which said non-connected and non-affixed container or containment means can be ingested or inserted into a live body.
Many studies show that age is strongly correlated to the number of prescription medication Pills a person is taking. Due to a continually increasingly aging population and increased use of drug therapy, more and more older people find themselves often taking several (perhaps as many as 4 to 10) Pills for treating or preventing illnesses every day. Research has shown that even patients for whom strict adherence to prescribed drug regimens is crucial, rates of non-compliance can still range from as much as 20% to 50%.
Each year in the United States, the consequences of poor compliance cost an estimated $100 billion in added health care expenses, lost productivity, and other direct and indirect costs, in addition to personal suffering.
Another consequence of people having to take several Pills every day, is that it increases the risk of mix-ups, for example, the patient becomes confused as to whether they have taken their medications or not. It is then possible that they take too much or too little of their medications; this results in side effects from drugs more likely to happen.
It is sadly ironic that the more confused the patient is, the more likely it is that they have even more Pills to keep track of and monitor.
According to the United States Food and Drug Administration, 1.5 million Americans were hospitalized in 1978 alone as a consequence of pharmaceutical drugs administered to “cure” them, It was found that some 30% of all hospitalized people suffered further damage from the therapy prescribed to them.
Side effects involving prescription drugs are the fifth leading cause of deaths in the USA.
One means of increasing compliance is to reduce the number of Pills taken per day, thus reducing patient resistance to swallowing large numbers of Pills or the possibility of patients forgetting to take some of their medication, thus reducing the number of Pills taken per day, and reducing the risk of medication-induced error.
Moreover, numerous studies have shown that certain combinations of different substances or medications can dramatically improve the health outcomes through additional or synergic effects. But these combinations most often require the ingestion of more Pills which may again lower the compliance.
The delivery of medication products, including prescription drugs, over-the-counter drugs, nutritional supplements and inert materials, has been traditionally accomplished by the use of Pills.
Typically Pills are comprised of the active ingredient compounded with inert ingredients for various purposes, including ease of handling small amounts of active ingredients. When the said mixture of active and inactive ingredients is then compressed to form a “pill”, that pill typically is then coated or covered with a polished “surface” substance functioning as both a physical/chemical barrier and as a helper for smooth swallowing. Very often medications can come in a dose of only a few milligrams, but since this amount is so small and unmanageable, the size of the pill has to be increased substantially with fillers
Similarly, capsules, gel caps and soft-gels are composed of an outer material or casing which is dissolved after ingestion by the patient. The interior portion of the capsule, gel caps or soft-gel is filled with an active ingredient compounded with inert ingredients for various purposes, including ease of handling of small amounts of active ingredients, similar to a pill as described above.
There are several distinctions between capsules vis-à-vis soft gels or gel caps. The major difference between a capsule and a soft gel or gel cap is that a capsule is a hard shell and a soft gel or gel cap is physically a softer gelatin container. A soft gel or gel cap is essentially a capsule made from gelatin, usually from a bovine or pig source, although there are also available soft gels made from vegetable sources, e.g., potato starch. A capsule, on the other hand, is generally made from many different materials, including gelatin formulations. Capsules usually contain solid materials such as powders, although they occasionally do contain liquids, whereas soft gels or gel caps usually contain oils or liquid, although some soft gels or gel caps do contain rather powdery substances in soft gels or gel caps, which facilitate the swallowing process.
A sub-category or variation of gel caps is “liquid gel caps”. The interior of these gel caps are filled with liquid rather than solid materials, typically a blend of active and inactive ingredients. The liquid gel caps provide an easy means of carrying liquid medications for ingestion without the need to transport the liquid from a liquid container to the mouth of the patient. Thus the risk of liquid bottle spillage or breakage is avoided.
The disadvantage of a typical prescription Pill is that it usually contain only one primary medication thus only addresses one type of indication or problem.
The treatment of many seriously ill or chronic patients requires the use of multiple medications. Many patients find having to take numerous traditional Pills is burdensome and restrictive, and causes additional responsibility and worries. Not only is the patient burdened with multiple containers for the various medications, but the patient must also track each Pill to assure that they have in fact timely ingested the proper dosage of each such medication.
To generate a “tracking system”, it is well known many patients hesitate to switch to cheaper generic substances, because patients use, for example, the heart shaped form of medication for one ailment or the soothing shade of sky blue color of medication for another ailment to help them recognize their medication. The pharmaceutical industry brands their drug products by offering them in a wide array of different shapes, sizes and colors. Although this helps the patient to recognize their numerous individual Pills, but it also makes prescription medication treatment more expensive than necessary. This is due not only to production and marketing costs but also because the patients are hesitant to try unrecognizable generic versions.
The present invention reflects the fact that: (1) Most people do not experience any problems swallowing oblong capsules up to the size of eight (8) mm in diameter and twenty (20) mm to twenty five (25) mm in length, although this size is somewhat larger than most of the prescription Pills on the market; (2) Keeping track of one large Pill is easier than keeping track of numerous small Pills; (3) Many prescription drugs come in Pill sizes larger than chemically necessary and the active ingredient is often so minute it needs to be sized up with fillers to become manageable for the consumer, or it needs to fit a specific shape for marketing purposes; and (4) There are presently no national or international standards for sizes, shapes or colors for Pills; instead even the same generic component can come in a variety of appearances to reflect the manufacturers brand. This makes it confusing and difficult for the patient to switch from one manufacturer to another for the same medication.
Combining the fact that it is physically possible to add many prescription drugs together in one ingestible unit, and still maintain a Pill size which is easier to swallow, opens up the possibility of solving the above compliance problems and reducing the risk of taking too much or little medication.
An objective of the present invention is to solve the aforesaid problems, including by reducing the number of Pills that will contain the originally intended, prescribed or recommended medications and doses, thus increasing compliance and reducing the possibility of confusion.
A further objective of the present invention is also to solve the aforesaid problems by is that by facilitating a switch, in certain instances, to relatively less expensive generic products.
A yet further objective of the present invention is also to solve the aforesaid problems by enabling a world wide patient individualized manufacturing systems/fulfillment centers/pharmacies based on international standards for size and configuration of Pills.